MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCK; I.V. SET STOPCOCK

Catalog Number 394602

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1063368.Medical device expiration date: 02/29/2024.Device manufacture date: 04/16/2021.Medical device lot #: 9255095.Medical device expiration date: 08/31/2022.Device manufacture date: 10/15/2019.Medical device lot #: 1084430.Medical device expiration date: 02/29/2024.Device manufacture date: 04/16/2021.Medical device lot #: 1061609.Medical device expiration date: 02/29/2024.Device manufacture date: 03/31/2021.Medical device lot #: 9270579.Medical device expiration date: 08/31/2022.Device manufacture date: 10/15/2019.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported 6 bd connecta¿ 3-way stopcocks had leakage issues.The following information was provided by the initial reporter, translated from (b)(6): ¿the anesthesia department has determined that when using the [tri-extension set] connected the 3-way-stopcok.Propofol leaks drop by drop, it does not matter how tight the connection is.¿.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-12-16 investigation summary : our quality engineer inspected the 10 samples, consisting of the reported lots 1063368, 9255095, 1084430, 1061609 and 9270579, submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the samples.All 10 samples underwent our internal leakage testing and none showed any signs of leakage.Bd cannot confirm the cause of the failure to our manufacturing process since no defect was observed during leakage testing on any of the samples.A device history record review showed no non-conformances associated with this issue during the production of these batches.

Event Description

It was reported 6 bd connecta¿ 3-way stopcocks had leakage issues.The following information was provided by the initial reporter, translated from german: ¿the anesthesia department has determined that when using the [tri-extension set] connected the 3-way-stopcok.Propofol leaks drop by drop, it does not matter how tight the connection is.¿.

• Brand Name: BD CONNECTA¿ 3-WAY STOPCOCK
• Type of Device: I.V. SET STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12823737
• MDR Text Key: 284970178
• Report Number: 9610847-2021-00550
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 394602
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1